Model Number 106 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Unspecified Infection (1930); Nerve Damage (1979); Paresis (1998); Vomiting (2144); Weight Changes (2607)
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Event Date 11/28/2018 |
Event Type
Injury
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Event Description
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It was reported that post surgery, the patient had not been eating and had been vomiting.The patient also had a higher number of autostimulations than prior to their replacement.Further information received indicated that it was unknown if the patient¿s generator had died prior to replacement.The physician did not believe that the vomiting and weight loss is related to an illness or to compromised immune system post surgery.The patient saw a gastroenterologist, and had a v-tube and bypass to the duodenum and was placed on a feeding tube.It was indicated that there was a gastric issue; however, it is unknown if that is the sole cause of the nausea and vomiting, or if there was additional factors.The physician was concerned to disable the device because the patient is on many medications and has gone into status in the past.The physician also questioned if the patient¿s nerve had been pulled during the recent replacement surgery.The sales representative present at the surgery denied the surgeon having pulled on the nerve, and stated that surgeon believed the vomiting was unrelated to vns.The patient was hospitalized and his device was disabled.Per the physician, the patient immediately improved when the device was disabled.No additional or further information has been received to date.
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Event Description
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It was reported on vns therapy facebook page by a patient¿s mother that her son¿s eighth battery replacement damaged the vagus nerve, and now the only way he keeps food down is through anti-vomiting medications.The mother had previously commented that her son had gastroparesis and nerve damage, and had lost 25 lbs in three months.She also stated that the patient¿s vagal nerve was inflamed or damaged during replacement.Prior to her comment on (b)(6) 2019, there was not enough identifying information to conclude who the patient was.This was previously reported with an unknown patient in mfr report #1644487-2019-00318.Based on the number of replacements and timeframe, this report was found to be related to the vomiting and weight loss previously reported for the mother on facebook in mfr report # 1644487-2019-00017.Any additional or relevant information related to this event will be reported under mfr report #1644487-2019-00017.No additional information has been received after multiple attempts to the physician.No additional or relevant information has been received to date.
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Manufacturer Narrative
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Describe event or problem; corrected data: infection had previously been inadvertently included in this report (mfr report 1644487-2019-00017).This has been reported separately in mfr report 1644487-2019-00248.
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Event Description
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Additional programming history was received and reviewed.There were no anomalies seen.Information was received from the surgeon.He was not sure of the cause of the patient¿s symptoms, and had not been able to determine a physiological cause.He stated that he has previously performed many generator changes on the patient due to prophylactic replacement, and the procedure remained essentially the same.There were no other external factors that could be identified.No additional information has been received.
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Event Description
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It was reported that the patient¿s device was attempted to be turned back on and the patient began to get sick again.The patient¿s device was disabled, leaving only the magnet mode turned on.The physician believes the problem is due to the vns.Information was received from the physician¿s office that there are no other known causes for the patient¿s reported issues.The patient¿s generator was placed in the same place as the previous generator.The patient did not have a history of gastro-intestinal issues and there were no medication changes prior to the replacement.Clinic notes were reviewed.The patient had tested positive for methicillin resistant staph aureus.Device history records were reviewed for the generator and lead.The devices were sterilized prior to distribution.Programming history was reviewed.No anomalies were seen.The patient¿s autostimulation threshold settings had been lowered on their new device, which is likely the cause of the increase in autostimulation.No further information has been received to date.
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Search Alerts/Recalls
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